WO2019045321A1

WO2019045321A1 - Intraoperative nerve monitoring system using bio pressure sensor

Info

Publication number: WO2019045321A1
Application number: PCT/KR2018/009287
Authority: WO
Inventors: 이병주; 노정훈
Original assignee: 부산대학교 산학협력단
Priority date: 2017-08-30
Filing date: 2018-08-13
Publication date: 2019-03-07
Also published as: KR20190023914A; KR102062252B1

Abstract

The present invention provides an intraoperative nerve monitoring system using a bio pressure sensor. The intraoperative nerve monitoring system using a bio pressure sensor, according to the present invention, has technical features of: measuring, by using the bio pressure sensor, a surface pressure change in a contact surface of a skin or a muscle, occurred by a movement of the corresponding muscle; wiredly or wirelessly transmitting the measured pressure change so as to allow a user to identify nerve through a visual graph or an auditory alarm sound; and further, transmitting the measured result to a portable device through wireless communications such that the result can be easily checked in the portable, unlike the conventional methods of inserting an electrode or measuring an action potential change caused by a muscular movement of a human body surface so as to identify a part corresponding to nerve for preventing complications caused by a neural damage during surgery, and to measure an electromyogram of a corresponding muscle according to neural stimulation.

Description

Neuro-surveillance system using bio-pressure sensor

The present invention relates to an intraoperative neural surveillance system using a bio-pressure sensor, and more particularly, to a neural surveillance system using a bio-pressure sensor, and more particularly, In order to measure the EMG of the muscles, the pressure change at the contact surface of the skin or muscles caused by the movement of the muscle is measured using a bio-pressure sensor, not by inserting a conventional electrode or measuring the action potential change due to the muscle movement of the human body surface And the measured pressure change is transmitted by wire or wireless so that the user can visually confirm the nervousness through a graph or an audible alarm. Further, the measured result is transmitted to the mobile device through wireless communication, Using a bio-pressure sensor that allows easy identification To an intraoperative nerve monitoring system.

The precise identification of the nerve of the recipient in performing the surgery is an important part of preventing complications from nerve injury in many surgical procedures such as otorhinolaryngology, brain surgery, thoracic surgery, spine surgery, or orthopedic surgery. In other words, during surgery, such as spinal surgery, ear surgery, thyroid surgery, and parotid surgery, an intraoperative neurological surveillance system is used to continuously monitor the nerve area of the patient during surgery. During this operation, the neural surveillance system is very helpful in preventing complications due to nerve injury that may occur even during surgery of the patient.

Electromyography is a technique for measuring and recording electrical signals from skeletal muscles. The conventional neural surveillance system is a system for assessing whether or not a nerve is affected by electrical stimulation of a structure suspected to be a nerve by electromyography according to the movement of the muscle. In other words, the nerve stimulation is performed using a separate nerve probe, as shown in FIG. 1, which can provide electrical stimulation separately from the medical instrument that performs surgery during surgery, and then the electromyogram generated by the nerve stimulation is inspected .

The method of measuring the EMG of the muscle varies depending on the region, but for the EMG measurement, a needle electrode method for inserting a needle-shaped electrode as shown in FIG. 2 into the muscle, And the surface derivation method in which the same electrode is attached to measure the action potential of the muscles.

The needle electrode method can reflect the electromyogram of the corresponding muscle, but the need for inserting the needle into the muscle causes pain, infection by the needle and bleeding. In addition, the thyroid gland in thyroid surgery, the needle can not be inserted in the position can not use the needle electrode method.

Therefore, a surface derivation method is used to measure the action potential of the vocal cord muscle by using an electrode that can be attached to the electromyographic or intubation intubation tube fixed on the surface of the airway intubation tube as shown in FIG.

However, this surface derivation method requires that all of the two electrodes should be in contact with the vocal cords in an attached EMG to the tube for tracheal intubation. If one of the electrodes is displaced and the vocal cord contact is incomplete, the neural surveillance system will fail to operate . In other words, if the electromyographic electrode inserted or attached to the tube is moved due to the change of the posture of the patient or the insertion direction of the intubation tube, if one electrode moves and the contact with the vocal cords is poor, EMG can not be measured.

Electrophysiographic measurement using fixed or attachable electrodes on the surface of the intubation tube used frequently for thyroid surgery has the problem that accurate EMG can not be measured due to interference or noise due to needle or spatula.

Conventional Korean Patent Registration No. 10-1270935 An apparatus and method for monitoring a nervous system during surgery can simultaneously monitor the nervous system of a subject during surgery using peak amplitude and peak time of excitation potential and are not bound to various kinds of stimuli &Lt; / RTI >

However, there is a case where nerve damage occurs even when the conventional neural surveillance system is used. One of the causes of nerve injury during surgery is a case where the neuron in the abnormal position is cut without recognizing the nerve. That is, since the conventional neural surveillance system is a method of identifying the nerve by giving electrical stimulation to the suspected part of the nerve during surgery as an extra nerve probe, the nerve probe is not performed by the nerve probe There is a case where the neural surveillance system is not able to prevent nerve damage because of the error of the neural surveillance system due to the change of the position of the tube.

Also, Korean Patent Laid-Open No. 10-2009-0115162 discloses a surgical navigation and neural surveillance integrated system with automated surgical assistance and control, including an instrument tracking system configured to track movement of the instrument, And a database containing technical information about the patient's anatomy; And determining an anatomical structure proximate to the instrumentation tracking system and the database, the anatomical structure proximate the instrumentation; Determining a portion of the technical information associated with the anatomical structure included in the database; And identifiers for a portion of the descriptive information in a user-selectable manner that allows the user to selectively obtain descriptive information in connection with either the surgical procedure or the anatomical structure. Wherein the computer is configured to automatically determine an electrostimulation pattern from the location of the neural structure and to electrically stimulate the neural structure according to the determined electrical stimulation pattern, To an apparatus that is further programmed to control the neural surveillance system.

However, even in the case of the surgical navigation system and the neural surveillance integrated system, the above-described pattern of the electrical stimulation is automatically determined, which is a limitation of the conventional needle electrode method.

Accordingly, the present invention has been made to solve the above problems of the prior art, and it is an object of the present invention to provide a method and apparatus for measuring electromyography by electrical stimulation in order to confirm a nervous state during surgery, In the case of the vocal cord muscle, a bio-pressure sensor is attached to the surface of the intubation tube tube in the form of a tape so that the insertion of a needle corresponding to at least two electrodes for conventional electromyography And to eliminate the instability of measurement signals caused by acupuncture or sputum by eliminating the risk of pain, hemorrhage or infection due to contact failure due to movement of the vocal fold muscle in contact with the two electrodes of the intubation intubation tube And furthermore, the pressure value at the contact surface of the skin or muscle, which is the analog value measured from the bio pressure sensor With a new bio-pressure sensor that can be easily accessed by a user's portable device such as a doctor using a wireless communication technology by converting the digital signal into a digital signal. do.

According to an aspect of the present invention for achieving the above object, the present invention provides a surgical operation method for a surgeon who is suspected of being an area corresponding to a nerve during surgery, A nerve probe that performs stimulation, and a portion located between the skin and the contact surface of the body's muscles and muscles, stimulates the region where the nerve is suspected through the nerve probe, and when the region corresponds to the nerve, A bio-pressure sensor for detecting a change in pressure due to movement of the muscle, and a bio-pressure sensor for detecting movement of the muscle due to electrical stimulation generated by the nerve probe, and transmitting the detected pressure change to the output device A microcontroller; And an output device for receiving a digital signal corresponding to a pressure change received from the microcontroller and outputting the digital signal to a user.

The bio-pressure sensor of the intraoperative nerve monitoring system using the bio-pressure sensor according to the present invention can be applied to a pressure sensor using a mechanical pressure sensor, an electric pressure sensor, a semiconductor pressure sensor, a strain gauge, a displacement sensor, Is measured.

The microcontroller of the intraoperative neural surveillance system using the bio pressure sensor according to the present invention according to the present invention detects the bio-pressure sensor 120 at a predetermined period after the electric stimulation is applied to the nerve by the nerve probe 110, An A / D converter for converting an analog signal corresponding to a change in pressure transmitted from the detector into a digital signal; And a communicator for transmitting the digital signal corresponding to the pressure change converted from the A / D converter 134 to the output device 140 in a wired or wireless manner.

According to the intraoperative neural surveillance system using the bio pressure sensor according to the present invention, in the method of measuring the EMG for precisely confirming the nerve in performing the surgery, the change of the muscle resulting from the electrical stimulation to the nerve is compared with the conventional needle It is possible to eliminate the risk of pain, hemorrhage or infection due to electrode needle insertion for measuring EMG by the conventional needle electrode method, It is possible to prevent an error in a measurement signal due to interference or noise caused by a nerve cut and a liquid such as a needle or sputum caused by unmeasured measurement caused by not contacting all the two electrodes of the intubation intubation tube, Instead of expensive medical devices that output changes, the skin or muscle measured using a bio-pressure sensor By a change of pressure in the contact surface is converted into the digital signal can be easily can confirm the measured value so reduce costs from a mobile device, the effect capable of providing convenience to users.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an illustration of a neural probe that stimulates a nerve to probe a conventional neural path according to an embodiment of the present invention; FIG.

FIG. 2 is an illustration of a two-pole needle electrode used in a needle electrode method for electromyography according to an embodiment of the present invention; FIG.

3 is an illustration of a two-dimensional surface electrode used in a surface derivation method for EMG measurement according to an embodiment of the present invention;

FIG. 4 illustrates an example of a tracheal intubation tube for insertion of a vocal cord using a surface derivation method according to an embodiment of the present invention;

FIG. 5 is a block diagram of an intraoperative nerve monitoring system using a bio-pressure sensor according to an embodiment of the present invention; FIG.

6 (a) is an exemplary view of a contact type bio pressure sensor according to an embodiment of the present invention;

FIG. 6 (b) is a comparative experiment of a conventional needle electrode for rabbit hind leg muscles and a contact type bio pressure sensor according to an embodiment of the present invention; FIG.

FIG. 7A is an exemplary graph of an amplitude graph of an electromyogram measured on a rabbit hindlimb muscle using a conventional needle electrode method; FIG.

FIG. 7 (b) is a graph illustrating an amplitude graph of an electromyogram measured on a rabbit hind leg muscle using a contact type bio pressure sensor according to an embodiment of the present invention;

8 (a) is a view showing the shape of a contact type pressure sensor attached to a tracheal intubation tube for insertion of a vocal cord according to an embodiment of the present invention;

FIG. 8 (b) is an experimental drawing of a pressure sensor on the laryngeal nerve and stimulating the exposed laryngeal nerve with a nerve probe;

9 is a block diagram of a microcontroller of an intraoperative nerve monitoring system using a bio pressure sensor according to an embodiment of the present invention;

10 is an exemplary view of an EMG output apparatus received from a communicator of an intraoperative nerve monitoring system using a bio pressure sensor according to an embodiment of the present invention.

An intraoperative nerve monitoring system 100 using a bio pressure sensor according to an embodiment of the present invention includes a nerve probe 110, a bio pressure sensor 120, a microcontroller 130, and an output device 140 .

The neurological probe 110 performs electrical stimulation when the surgeon uses the surgical instrument 10 to perform a surgical operation in a surgical tissue, do. The nerve probe 110 contacts the suspected portion of the nerve and applies a current from a power supply (not shown) to give a fine electrical stimulus.

The surgeon generally uses the surgical instrument 10 to find a suspected nerve area during surgery. When the surgeon places the surgical instrument 10, the surgeon substitutes the nerve probe 110 for electric stimulation to the nerve. Recently, 10-1731004 entitled " Energy Device Surgical Instrument Attached with a Neural Probe " discloses a surgical instrument in which a surgical instrument 10 and a neural probe 110 are integrated.

The bio-pressure sensor 120 is positioned between the skin and the contact surface contacting the muscles and muscles of the body. If the stimulus is given to the suspicious part through the nerve probe 110, if the corresponding part is the nerve, The movement of the muscles due to the electrical stimulation by the stimulation unit 110 occurs, and the change of pressure due to the movement of the muscles is sensed. The bio-pressure sensor 120 can measure pressure by various methods of measuring pressure, such as mechanical pressure sensors, electrical pressure sensors, semiconductor pressure sensors, strain gauges, displacement sensors, acceleration sensors, and optical sensors.

6 (a) is an exemplary view of a contact-type bio-pressure sensor according to an embodiment of the present invention.

6 (a), the bio-pressure sensor 120 attaches a thin tape-type bio-pressure sensor to the contact surface of the skin or muscles so that the pressure change on the skin or muscle contact surface due to the movement of the muscle Detection.

6 (b) is a comparative experimental view of a conventional needle electrode for a rabbit hind leg muscle and a contact type bio pressure sensor according to an embodiment of the present invention.

6 (b), in measuring the electromyogram of the hind leg muscles of the rabbit by electrical stimulation by the nerve probe 110, a comparative experiment using a conventional needle electrode method and a contact type bio-biometric pressure sensor However, when the conventional needle electrode method is used, there is a risk of pain, bleeding, or infection due to needle insertion, but the non-invasive method using the bio pressure sensor 120 is used.

7 (a) is a graph showing an amplitude graph of an electromyogram measured on a rabbit hind leg muscle using a conventional needle electrode method, and FIG. 7 (b) FIG. 2 is a graph showing an amplitude graph of an electromyogram measured using a rabbit hindlimb muscle. FIG.

As shown in FIG. 7 (a), when the muscle of the rabbit hind leg is subjected to 1 mA of nerve stimulation using the neural probe 110, measurement is performed through the conventional inserted needle electrode measured in FIG. 6 (b) As shown in Fig. 7 (b), the pressure change at the contact surface of the skin or muscle due to the muscle movement measured by the attachment type bio-pressure sensor by the nerve stimulation of 1 mA, which is the same environment And a graph is presented by converting the analog signal to a digital signal. The amplitude values for the nerve stimulation can not be compared in the two methods, but it can be seen that the movement of the muscles by the nerve stimulation can be perceived in the same way.

8 (a) is a view showing the shape of a pressure sensor attached to a tracheal intubation tube for insertion of a vocal cord according to an embodiment of the present invention, FIG. 8 (b) It is an experiment to stimulate the exposed laryngeal nerve with a neural probe.

As shown in FIG. 8 (a), in the airway intubation tube for the insertion of the sacroiliac joint, an arrow mark is attached to the surface of the airway intubation tube in place of the two electrodes attached to the electromyogram measurement using the conventional surface derivation method Type bio pressure sensor 120 to measure the pressure change due to the movement of the vocal cord muscles according to the nerve stimulated by the nerve probe 110. [ The bio pressure sensor 120 may be installed to surround the surface of the intubation intubation tube or may be installed to surround the surface of the intubation intubation tube by expanding the area of the bio pressure sensor 120.

Since the bio-pressure sensor 120 installed on the surface of the intubation tube of the intubation measures changes in pressure, it is difficult to determine whether the nerve is present or not due to the fact that the two electrodes are not in contact with each other in the EMG measurement by the conventional surface derivation method. It is possible to eliminate measurement errors due to electrical interference or signal noise due to a liquid component such as dust or sputum.

FIG. 8 (b) is a graph showing the results of stimulation of the nerve by the nerve probe 110 indicated by arrows on the exposed laryngeal nerve after thyroid surgery in a pig anesthetized with the intubation tube with the bio-pressure sensor 120 attached thereto, And an output device 140 is provided to check the movement of the vocal cord muscle measured by the bio-pressure sensor 120 attached to the intubation tube.

9 is a microcontroller configuration diagram of an intraoperative nerve monitoring system using a bio pressure sensor according to an embodiment of the present invention.

9, the microcontroller 130 comprises a configuration including a detector 131, a filter 132, an amplifier 133, an A / D converter 134 and a communicator 135, The bio-pressure sensor 120 detects the movement of the muscle due to the electrical stimulation generated by the bio-sensor 110 and transmits the detected pressure change to the output device 140.

The detector 131 detects a change in pressure according to the movement of the muscle measured from the bio pressure sensor 120 at a predetermined period after the electrical stimulation of the nerve occurs with the nerve probe 110. When electrical stimulation is performed on a certain part of the body using the nerve probe 110, muscle movement occurs after a certain interval when corresponding to the nerve.

Movement of the muscles due to other factors other than the nerve probe 110 is not related to the technique of the neural surveillance system to detect whether or not it is a nerve during surgery. Therefore, the detector 131 detects whether electrical stimulation of the nerve probe 110 is generated, and then detects a change in pressure according to the movement of the muscle measured by the bio-pressure sensor 120.

The filter 132 removes high frequency or low frequency signals that can be added as noise to the change in pressure transmitted from the detector 131. In the case of the bio-pressure sensor 120, noise may be generated due to the precision, so that the noise can be removed by using the filter 132 to exhibit a more accurate pressure change.

The amplifier 133 increases the amplitude according to the noise-removed pressure change through the filter 132. [ Since it is very important to accurately identify the nerve during surgery, the filter 132 is connected to the amplifier 133 through the amplifier 133 so that the change of the pressure can be easily confirmed so that the movement of the muscle due to the stimulation of the nerve can be more accurately confirmed. It is necessary to amplify the input signal.

The A / D converter 134 converts an analog signal corresponding to a change in pressure transmitted from the detector 131 or the amplifier 133 into a digital signal. As the development of the digital device and the resolution of the analog signal are improved, many recent devices that receive, output or transmit the measured values from the sensor use digital signals, And converts the analog signal into a digital signal through the A / D converter 134. [

The communicator 135 transmits the digital signal corresponding to the pressure change converted from the A / D converter 134 to the output device 140 by wire or wirelessly. The communicator 135 transmits the digital signal corresponding to the pressure change to the output device 140. The communication device 135 transmits the digital signal in response to the pressure change to the output device 140. In the case of wireless such as WiFi and Bluetooth, Lt; / RTI >

10 is an exemplary diagram of an electromyography output device of an intraoperative nerve monitoring system using a bio pressure sensor according to an embodiment of the present invention.

10, the output device 140 receives a digital signal corresponding to the pressure change received from the communicator 135 of the microcontroller 130, and outputs the digital signal to the user. The output device 140 may be visually represented graphically or audibly through a warning tone so that the user can easily recognize whether the user is nervous during surgery.

Output device 140 may be typically a wired or wireless monitor 141 that provides a visual display and may also appear through the user's portable device 142 using wireless communication and may also include an audible beep Can be output together.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS In order to fully understand the present invention, a preferred embodiment of the present invention will be described in detail with reference to the accompanying drawings 1 to 10. The embodiments of the present invention may be modified into various forms, and the scope of the present invention should not be construed as being limited to the embodiments described in detail below. The present embodiments are provided to enable those skilled in the art to more fully understand the present invention. Therefore, the shapes and the like of the elements in the drawings can be exaggeratedly expressed to emphasize a clearer description. It should be noted that in the drawings, the same members are denoted by the same reference numerals. In the drawings and the detailed description, the construction and operation of the surgical instrument, the neural probe, the intubation tube, and the neural surveillance system can be easily understood by those skilled in the art. Particularly, in the drawings and the detailed description of the drawings, detailed description and illustration of elements and structures of elements that are not directly related to the technical features of the present invention are omitted and only a technical structure related to the present invention is shown briefly .

5 is a configuration diagram of an intraoperative nerve monitoring system using a bio pressure sensor according to an embodiment of the present invention.

5, the intraoperative nerve monitoring system 100 using the bio pressure sensor according to an embodiment of the present invention includes a nerve probe 110, a bio pressure sensor 120, a micro controller 130, (140).

6 (b), in the measurement of the electromyogram of the muscle of the hind leg of the rabbit by electrical stimulation by the nerve probe 110, a comparative experiment using a conventional needle electrode method and a contact type biosensor, There is a risk of pain, bleeding, or infection due to needle insertion, but the non-invasive method using the bio-pressure sensor 120 is used.

The communicator 135 transmits the digital signal corresponding to the pressure change converted from the A / D converter 134 to the output device 140 by wire or wirelessly. The communicator 135 transmits the digital signal corresponding to the pressure change to the output device 140. In the case of wireless such as WiFi and Bluetooth, Lt; / RTI >

Although the intraoperative nerve monitoring system using the bio pressure sensor according to the embodiment of the present invention has been described with reference to the above description and drawings, it should be understood that the present invention is not limited to the described embodiments, It will be understood by those skilled in the art that various changes and modifications may be made therein without departing from the spirit and scope of the invention.

The surgical nerve monitoring system using the bio-pressure sensor of the present invention is a system for measuring the electromyography of a corresponding muscle according to nerve stimulation in order to identify a portion corresponding to a nerve in order to prevent complications due to nerve damage during surgery, The pressure change on the surface of the skin or muscle caused by the movement of the muscle is measured using a bio-pressure sensor, and the measured pressure change Can be transmitted by wire or wireless so that the user can be visually confirmed through a graph or an acoustic warning sound. Further, the measured result can be transmitted to a portable device through wireless communication and can be easily confirmed on a portable device. It is available in the medical field for related surgery. High.

Claims

A neurostimulator that performs electrical stimulation when a surgeon performs a surgical operation and the surgeon suspects that the surgeon is suspected to be a site corresponding to a nerve to perform surgery;

It is located between the skin and the contact surface of the body that is in contact with the muscles and muscles of the body. If a stimulus is given to the suspected nerve region through the nerve probe, if the corresponding region is a nerve, muscle movement occurs, A bio pressure sensor for detecting a change in pressure;

A microcontroller for detecting a movement of a muscle due to electrical stimulation generated by the nerve probe by the bio pressure sensor and transmitting the detected pressure change to an output device; And

And an output device for receiving a digital signal corresponding to a pressure change received from the microcontroller and outputting the digital signal to a user.
The method according to claim 1,

The bio-pressure sensor includes:

An intraoperative neural surveillance system using a bio pressure sensor, characterized in that the pressure is measured using a mechanical pressure sensor, an electric pressure sensor, a semiconductor pressure sensor, a strain gauge, a displacement sensor, an acceleration sensor, and an optical sensor.
3. The method according to claim 1 or 2,

The microcontroller,

A detector for detecting a change in pressure according to movement of the muscle measured from the bio pressure sensor at a predetermined period after electrical stimulation of the nerve occurs with the nerve probe;

An A / D converter for converting an analog signal corresponding to a change in pressure transmitted from the detector into a digital signal; And

And a communicator for transmitting the digital signal corresponding to the pressure change converted from the A / D converter to the output device by wire or wireless.